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Pfizer receives European approval for new multi-dose vial presentation of Prevenar 13®

 

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Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). This new MDV presentation was developed to help maximize efficiency for health care workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing.

The MDV presentation of Prevenar 13® offers significant benefits to developing countries, including a 75 percent reduction in: Temperature-controlled supply chain requirements, United Nations International Children’s Education Fund (UNICEF) shipping costs, and Storage requirements at the national, regional, district, and community levels.

Pfizer plans to submit its Prevenar 13® MDV presentation to the World Health Organization (WHO) for prequalification, which, if and when approved, will allow for the global use of this new presentation of Prevenar 13® by United Nations agencies and countries worldwide that require WHO prequalification. If and when prequalified, the MDV presentation is expected to be introduced under the Advance Market Commitment program in early 2017, for shipment to countries covered by Gavi, the Vaccine Alliance (Gavi). This presentation will be available at a lower price of $3.10 per dose.

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